Title: Associate Director, Analytical Development, MSAT
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
The Associate Director of Analytical Development position reports to the Senior Director of Analytical Development within the CMC organization at TG Therapeutics, and is responsible for managing the effective execution of analytical development, transfer, troubleshooting and validation of a range of analytical methodologies at a number of analytical contract testing sites. In addition, he/she will work closely as an analytical subject matter expert to support colleagues in our manufacturing group on in-process analytics, with our quality group on change controls, stability trending, investigations and compliance, and with our regulatory group on submissions to support and enable our global regulatory strategy. The individual will present data-driven recommendations to cross-functional leadership teams, based on their thorough and in-depth understanding of the analytical issues involved.
TG Therapeutics is a commercial stage, biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has recently received approval from the US FDA and the EU EMA for BRIUMVI® (ublituximab-xiiy), for the treatment of multiple sclerosis. As we continue with our product launch and pipeline growth, we are seeking to expand our MSAT group.
––Support and manage outsourced analytical methods across a global network of vendors for commercial and clinical biopharmaceutical drug substance and drug product manufacturing. This includes physicochemical, functional and compendial assays.
––Support the strategy and effectively guide and direct the execution of assay validation, transfer, optimization and development which is appropriate to the support of commercial and clinical manufacturing.
––Work closely with Quality and Manufacturing colleagues in support of and to analyze data relating to lot release testing, in-process testing, stability testing, stability analysis, characterization and assay qualification /validation.
––Help prepare and review CMC documentation for analytical sections of regulatory filings including post approval filings with US and EU
––Work closely with compliance groups, including QC testing, QA and regulatory.
––Work with cross functional teams to meet company goals.
––Analyze and trend testing results. Prepare and present clear data-driven verbal presentations, and propose solutions based on these data.
––Author and review clear and concise technical reports and other documentation.
––Experience with management of outsourced analytical work in a pharmaceutical development or commercial environment. Should include method development, validation, and transfer.
––Significant experience with analytical development and assay troubleshooting related to biologics. Experience should span several or all of chromatographic, immunoassay, residuals, and cell-based assay methodologies. Experienced with vector and gene therapies would also be of value, but the successful candidate should in any case demonstrate an ability to apply existing knowledgebase to become proficient in new assay modalities.
––A strong scientific mindset and ability to effectively interrogate data to build and communicate an understanding of assay and product behavior and to thereby justify data-driven proposals and recommendations.
––An understanding of the cGMP requirements of analysis of biopharmaceuticals.
––Familiarity with statistical analysis and statistical process control
––Effective written and oral communication skills.
––Remote position, available for infrequent travel including international.
––A can-do attitude of engaging effectively with problems to join a dynamic, team-based, small but growing biotech with a diverse range of opportunities for personal and professional growth.
––Occasional travel to support vendor management activities will be expected for this position.
PhD in chemistry, biochemistry, or related area with at least 7 years of relevant pharmaceutical/ biotech experience, or BS/MS with a corresponding equivalent number of years of relevant experience.
TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.